ORIGINAL RESEARCH–FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY Treatment of auricular hematoma by OK-432 Toshinori Kubota, MD, Nobuo Ohta, MD, PhD, Shigeru Fukase, MD, PhD, Yoshihisa Kon, MD, PhD, and Masaru Aoyagi, MD, PhD, Yamagata, Japan Sponsorships or competing interests that may be relevant to con- tent are disclosed at the end of this article. ABSTRACT OBJECTIVES: Intralesional injection therapy with OK-432 was developed as a therapy for operatively difficult lymphangioma (cystic hygroma) and is currently becoming a first-choice treat- ment for this disease. The aim of this article was to evaluate the outcome and complications of the treatment of patients with au- ricular hematoma by OK-432 therapy. STUDY DESIGN: Case series with planned data collection. SETTING: Yamagata University School of Medicine. SUBJECTS AND METHODS: We tried this therapy in 21 patients with auricular hematoma between January 2001 and Feb- ruary 2009. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hema- toma. We performed this treatment on an outpatient basis without hospitalization. RESULTS: Disappearance or marked reduction of the lesion were observed in all patients who had this therapy, and local scarring and deformity of the auricle did not occur in any patients. As for side effects, local pain at the injection site and fever (37°C-38°C) were observed in a few of the patients who had this therapy, but such problems resolved within a few days. CONCLUSION: These results may allow us to speculate that intralesional injection therapy with OK-432 is simple, easy, safe, and effective and can be used as a substitute for surgery in the treatment of auricular hematoma. © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. A uricular hematoma is commonly encountered in the otolaryngology clinic. It occurs because of blunt trauma to the auricle, and the properly unmanaged auricular hematoma can lead to infection, cartilage necrosis, contrac- ture, and neocartilage formation. 1-3 Although there are a variety of treatments aimed at preventing these complica- tions and returning the auricle to its pretrauma form, im- proper treatment can result in the conspicuous cauliflower ear deformity. 4-12 Thus, we have developed a new, simple, and safe method that can be used easily in private clinics and hospitals on an outpatient basis without hospitaliza- tion. 13 This method is intralesional injection therapy with OK-432. OK-432 (Picibanil; Chugai Pharmaceutical Co., Tokyo, Japan) was originally developed as an immunother- apy agent for cancer. It is thought that its immunopotenti- ating actions are caused by strong local inflammation that promotes the release of various cytokines. It is widely ac- cepted that OK-432 is very effective for reduction of ascites and pleural effusion in patients with carcinomatous perito- nitis and pleuritis. 13 When it is injected into the peritoneal or pleural cavity, reduction of ascites and pleural effusion occurs and adhesion of the cavity develops. Ogita et al first reported intracystic injection therapy with OK-432 for lym- phangioma in 1987. 14 This therapy has become a treatment of first choice for lymphangioma in Japan, because it is effective and safe. The purpose of this article is to study the effectiveness of intralesional injection therapy with OK-432 in patients with auricular hematoma. Subjects and Methods Subjects This was a prospective clinical study of patients with au- ricular hematoma receiving intralesional injection of OK- 432 from January 2001 to February 2009. Twenty-one pa- tients were diagnosed as having auricular hematoma during the study. The patients ranged from 15 to 78 years of age. All patients were male and were treated on an outpatient basis without hospitalization. No patients had penicillin allergy. This study was approved by the Institutional Re- view Board of our institution, and informed consent was obtained from each patient. Intralesional Injection of OK-432 We prepared 0.5 Klinische Einheit (KE) of OK-432 diluted with 0.2 mL saline solution. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hematoma. There was no resistance in cases of successful injection into the hematoma. Aspiration On the second day after the injection, the swollen auricular hematoma was punctured by a syringe with a 20-gauge needle, and the intralesional fluid was aspirated as much as possible. The intralesional fluid was relatively viscous, so it Received January 11, 2010; revised March 2, 2010; accepted March 3, 2010. Otolaryngology–Head and Neck Surgery (2010) 142, 863-866 0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2010.03.006 brought to you by CORE View metadata, citation and similar papers at core.ac.uk provided by Elsevier - Publisher Connector
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Otolaryngology–Head and Neck Surgery (2010) 142, 863-866
brought to you by COREView metadata, citation and similar papers at core.ac.uk
provided by Elsevier - Publisher Connector
ORIGINAL RESEARCH–FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY
Treatment of auricular hematoma by OK-432
Toshinori Kubota, MD, Nobuo Ohta, MD, PhD, Shigeru Fukase, MD, PhD,
Yoshihisa Kon, MD, PhD, and Masaru Aoyagi, MD, PhD, Yamagata, Japan
Sponsorships or competing interests that may be relevant to con- tent are disclosed at the end of this article.
ABSTRACT
OBJECTIVES: Intralesional injection therapy with OK-432 was developed as a therapy for operatively difficult lymphangioma (cystic hygroma) and is currently becoming a first-choice treat- ment for this disease. The aim of this article was to evaluate the outcome and complications of the treatment of patients with au- ricular hematoma by OK-432 therapy. STUDY DESIGN: Case series with planned data collection. SETTING: Yamagata University School of Medicine. SUBJECTS AND METHODS: We tried this therapy in 21 patients with auricular hematoma between January 2001 and Feb- ruary 2009. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hema- toma. We performed this treatment on an outpatient basis without hospitalization. RESULTS: Disappearance or marked reduction of the lesion were observed in all patients who had this therapy, and local scarring and deformity of the auricle did not occur in any patients. As for side effects, local pain at the injection site and fever (37°C-38°C) were observed in a few of the patients who had this therapy, but such problems resolved within a few days. CONCLUSION: These results may allow us to speculate that intralesional injection therapy with OK-432 is simple, easy, safe, and effective and can be used as a substitute for surgery in the treatment of auricular hematoma.
© 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved.
Auricular hematoma is commonly encountered in the otolaryngology clinic. It occurs because of blunt
trauma to the auricle, and the properly unmanaged auricular hematoma can lead to infection, cartilage necrosis, contrac- ture, and neocartilage formation.1-3 Although there are a variety of treatments aimed at preventing these complica- tions and returning the auricle to its pretrauma form, im- proper treatment can result in the conspicuous cauliflower ear deformity.4-12 Thus, we have developed a new, simple, and safe method that can be used easily in private clinics and hospitals on an outpatient basis without hospitaliza- tion.13 This method is intralesional injection therapy with OK-432. OK-432 (Picibanil; Chugai Pharmaceutical Co.,
Received January 11, 2010; revised March 2, 2010; accepted March 3, 2010.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Nec doi:10.1016/j.otohns.2010.03.006
Tokyo, Japan) was originally developed as an immunother- apy agent for cancer. It is thought that its immunopotenti- ating actions are caused by strong local inflammation that promotes the release of various cytokines. It is widely ac- cepted that OK-432 is very effective for reduction of ascites and pleural effusion in patients with carcinomatous perito- nitis and pleuritis.13 When it is injected into the peritoneal or pleural cavity, reduction of ascites and pleural effusion occurs and adhesion of the cavity develops. Ogita et al first reported intracystic injection therapy with OK-432 for lym- phangioma in 1987.14 This therapy has become a treatment of first choice for lymphangioma in Japan, because it is effective and safe. The purpose of this article is to study the effectiveness of intralesional injection therapy with OK-432 in patients with auricular hematoma.
Subjects and Methods
Subjects This was a prospective clinical study of patients with au- ricular hematoma receiving intralesional injection of OK- 432 from January 2001 to February 2009. Twenty-one pa- tients were diagnosed as having auricular hematoma during the study. The patients ranged from 15 to 78 years of age. All patients were male and were treated on an outpatient basis without hospitalization. No patients had penicillin allergy. This study was approved by the Institutional Re- view Board of our institution, and informed consent was obtained from each patient.
Intralesional Injection of OK-432 We prepared 0.5 Klinische Einheit (KE) of OK-432 diluted with 0.2 mL saline solution. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hematoma. There was no resistance in cases of successful injection into the hematoma.
Aspiration On the second day after the injection, the swollen auricular hematoma was punctured by a syringe with a 20-gauge needle, and the intralesional fluid was aspirated as much as possible. The intralesional fluid was relatively viscous, so it
k Surgery Foundation. All rights reserved.
864 Otolaryngology–Head and Neck Surgery, Vol 142, No 6, June 2010
was necessary to use a larger needle for aspiration at this time.
Follow-up All patients were regularly observed for a mean of 13.1 months (range 4-38 months) after the last injection. To treat fever, we gave analgesics for three to five days to all patients. Analgesics were prophylactically given to all pa- tients in the present study to treat potential fever. The auricular skin became red and indurated on the day after injection, and we punctured the skin over the auricular hematoma and aspirated the fluid on the second day after injection. We examined all patients on days 2, 7, 14, and 28 after OK-432 injection and judged the response between four and six weeks after injection. In case the response was insufficient, we repeated the same therapy with a 100 per- cent increase of OK-432. The “cure” and “marked reduc- tion” of auricular hematoma were defined, respectively, as a negative palpation and a decrease of more than one half compared with pretreatment size.
Results
A total of 21 patients were enrolled in this study. The demographic clinical data of 21 eligible patients are listed in Table 1. The mean age of patients was 43.1 years (range 15-78 years). Maximum hematoma diameters ranged from 2.7 to 6.7 cm (mean 3.8 cm). Twenty cases of auricular hematoma were cured (follow-up for more than 4 months after the last injection with no recurrence) after injection
Table 1
Sex Age Side Size No. of
injections Total
1 M 52 L 3.8 cm 1 0.5 2 M 41 L 3.5 cm 2 1 3 M 72 R 4.3 cm 1 0.5 4 M 16 R 6.7 cm 5 3.5 5 M 58 L 3.2 cm 1 0.5 6 M 29 L 2.9 cm 1 0.5 7 M 17 L 2.8 cm 1 0.5 8 M 53 R 3.6 cm 1 0.5 9 M 27 L 3.9 cm 1 0.5
10 M 55 L 4.1 cm 1 0.5 11 M 15 R 5.9 cm 3 2 12 M 45 L 4.0 cm 1 0.5 13 M 58 L 3.2 cm 1 0.5 14 M 36 R 4.6 cm 1 0.5 15 M 32 R 3.8 cm 1 0.5 16 M 78 R 2.7 cm 1 0.5 17 M 45 R 3.3 cm 1 0.5 18 M 19 L 3.8 cm 1 0.5 19 M 67 L 4.1 cm 1 0.5 20 M 35 L 3.2 cm 1 0.5 21 M 55 R 2.9 cm 1 0.5
KE, Klinische Einheit.
with OK-432 solution, administered one to three times. One patient had a marked reduction of auricular hematoma, but not a complete elimination, even after receiving the maxi- mum of five injections of OK-432 (case number 4). The number of treatments ranged from one to five (mean 1.3), and mean follow-up period was 13.1 months (range from 4 to 38 months). The outcome of OK-432 injection in auric- ular hematoma seemed not to depend on the size and loca- tion or the patient’s age. There were no serious complica- tions, although patients experienced fever (37.5°C-38°C ) for a few days after injection, usually controlled by antipy- retics. No infection or abscesses developed after OK-432 injections. None of the patients had evidence of scar on the skin at the injection site. Other side effects of the strepto- coccal preparation, such as post–rheumatic fever sequelae and glomerulonephritis, were not observed in any cases (Table 2). This therapy was undertaken for all patients with auricular hematoma on an outpatient basis without hospi- talization.
Discussion
There are various conservative and surgical treatments for auricular hematoma, including needle aspiration, short-term bolsters, incision and drainage, and drainage followed by application of a pressure dressing.1-12 Permanent elimina- tion of the dead space after evacuation of the hematoma has always been the main problem. Some patients are not suc- cessfully managed, and these procedures result in the conspicuous cauliflower ear deformity.2-12 OK-432 is a ly-
Follow-up Results Further treatment
30 months Cure None 4 months Cure None
12 months Cure None 38 months Marked reduction None 27 months Cure None 6 months Cure None 4 months Cure None
14 months Cure None 7 months Cure None 9 months Cure None
21 months Cure None 5 months Cure None
17 months Cure None 13 months Cure None 15 months Cure None 19 months Cure None 6 months Cure None 7 months Cure None 8 months Cure None 7 months Cure None 6 months Cure None
oma
dose
KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE
865Kubota et al Treatment of auricular hematoma by OK-432
ophilized streptococcal preparation made by penicillin treat- ment of the Su-strain of A-group streptococcus, and it was developed as an immunotherapy agent for cancer.13 When it is administered, strong local inflammatory reaction is caused by activation of neutrophils and monocytes, leading to cytokine production.15-17 Ogita et al first reported that intralesional injection therapy with OK-432 was effective for the lymphangioma.14 The working mechanism of OK- 432 in lymphangioma is that it immediately evokes inflam- mation and filtration of inflammatory cells into the cystic spaces. The accelerated lymph drainage and increased lymph flow lead to shrinkage of the cystic spaces. We reported that intralesional injection therapy with OK-432 was also effective in treatment of ranula.13 Roh et al have demonstrated that sclerotherapy with OK-432 was effective in treatment of branchial cleft cyst.18 OK-432 seems to be more safe and effective than other sclerosing agents such as boiling water, hypertonic saline, ethanol, tetracycline, cy- clophosphamide, sodium morrhuate, or bleomycin. How- ever, these sclerosing agents have shown limited success and systemic side effects of unpredictable scarring caused by spreading agents beyond the endothelial lining of the hematoma. Bleomycin can cause several side effects, in- cluding fibrosis of the lung.
Auricular hematoma arises from blunt trauma to the auricle. Shearing forces between the anterior auricular skin and underlying cartilage are believed to be responsible for the hematoma.1 The location of the hematoma has been classically described as between the perichondrium and cartilage; however, in some patient cases, hematoma can arise within the cartilage itself. OK-432 can induce very strong inflammation at the injection sites in auricular hema- toma. No deformity or infection was observed after sclero- therapy with OK-432.13,14,18,19 The complication rate of sclerotherapy is minimal. Sclerotherapy with OK-432 does not require patient admission or leave any scar on the skin at the injection site. Sclerotherapy is economically and cosmetically more advantageous than surgery. Our study is the first showing that auricular hematoma can be treated by the use of OK-432 in a larger patient series. Our study was limited by lack of a control group. Randomized controlled trials comparing OK-432 injection with simple aspiration, incision, or saline injection may be warranted. However, our results may be compared with historical control groups of simple aspiration and incision. Giles et al reported that the recurrence rates of needle drainage, incision and drainage with wick placement, and incision and drainage with mat- tress suture were 75 percent, 50 percent, and 5.3 percent, respectively.20 Needle aspiration alone and needle aspira- tion and drain placement are not sufficient treatments. Giles et al also reported 28 treatments in 23 ears. In the present study, 28 treatments were performed in 21 ears; however, 18 of 21 patients required only one treatment. Schuller et al demonstrated that only 14 of 24 patients with auricular hematoma were successfully treated initially.8 Two suffered
reinjury requiring treatment, and these ears were reported to
have slight thickening after healing.8 From the point of cost effectiveness, OK-432 therapy needs serial office visits, while agent and office treatment by the other modalities (aspiration, drainage) is considered inexpensive and re- quires no special equipment or medication. Regarding re- currence and number of required treatments, OK-432 ther- apy is at least comparable to other published techniques. There are collateral advantages regarding OK-432 therapy, as enumerated here: 1) The time for the procedure is brief, and it seems particularly suitable for children and other patients who cannot tolerate long procedures. 2) No local anesthesia was required during treatment. 3) The treatment was painless; therefore it can be well tolerated by children and nervous patients. 4) Secondary infection and hemor- rhage are rare. The auricular hematoma can be primarily treated with intralesional injection therapy with OK-432, several times if needed. A surgical procedure is only rec- ommended for cases with fibrous tissue and neocartilage formation.
Conclusions
Our results suggest that the treatment of auricular hematoma by OK-432 is simple, easy, safe, and effective therapy that results in complete or significant decrease in the volume of auricular hematoma, despite some incidence of recurrence. This therapy is a potentially curative procedure that may be used as a first-choice treatment for auricular hematoma
Table 2
Treatment Previous surgery, no. (%) 1 (5) Injected OK-432 solution
Median volume, mL (range) 0.2 (0.2-0.5) Median dose, KE (range) 0.55 (0.5-1) Total dose, KE (range) 0.55 (0.5-3.5) No. of treatments, median (range) 1.3 (1-5) Follow-up, months 13.1 (4-38) Further treatment 0
Response, no. (%) Cure 20 (95) Failure 0 Marked volume reduction 50%* 1 (5) Minimal volume reduction 50%* 0 Recurrence after cure 0
Side effects, no. (%) Low-grade fever 2 (10) Tolerable pain and local tenderness 4 (20) Local scar 0 Skin pigmentation 0 Auricular deformity 0
KE, Klinische Einheit. *Reduction of original hematoma size.
before considering surgical procedures.
866 Otolaryngology–Head and Neck Surgery, Vol 142, No 6, June 2010
Acknowledgment
This manuscript is dedicated to Professor Masaru Aoyagi, chairman, De- partment of Otolaryngology, Yamagata University, School of Medicine, who recently retired.
Author Information
From the Department of Otolaryngology, Yamagata University School of Medicine, Yamagata, Japan.
Corresponding author: Dr. Nobuo Ohta, Department of Otolaryngology, Yamagata University School of Medicine, 2-2-2, Iida-nishi Yamagata 990-9585 Japan.
E-mail address: [email protected].
This article was presented at the 2009 AAO–HNSF Annual Meeting & OTO EXPO, San Diego, CA, October 4-7, 2009.
Author Contributions
Toshinori Kubota, data analysis, article revision; Nobuo Ohta, concep- tion and data analysis, design, article revision, final approval; Shigeru Fukase, conception and design, article revision; Yoshihisa Kon, data analysis, article revision; Masaru Aoyagi, conception and design, final approval.
Disclosures
Competing interests: None.
Sponsorships: Supported by grants from the Ministry of Education, Sci- ence, Sports and Culture (Grant in Aids for Scientific Research C 19591955).
References
1. Ohlsen L, Skoog T, Sohn SA. The pathogenesis of cauliflower ear. Scand J Plast Reconstr Surg 1975;9:34–9.
2. Pandya NJ. Experimental production of cauliflower ear in rabbits. Plast Reconstr Surg 1973;52:534–7.
3. Stuteville OH, Janda C, Pandya NJ. Treating the injured ear to prevent cauliflower ear. Plast Reconstr Surg 1969;44:310–2.
4. O’Donnell BP, Eliezri MD, Eliezri YD. The surgical treatment of
traumatic hematoma of the auricle. Dermatol Surg 1999;25:803–5.
5. Henderson JM, Salama AR, Blanchaert RH. Management of auricular hematoma using thermoplastic splint. Arch Otolaryngol Head Neck Surg 2000;126:888–90.
6. Giffin CS. Wrestler’s ear: pathophysiology and treatment. Ann Plast Surg 1992;28:131–8.
7. Talaat M, Azab S, Kamel T. Treatment of auricular hematoma using button technique. ORL 1985;47:186–8.
8. Schuller DE, Dankle SD, Strauss RH. A technique to treat wrestler’s auricular hematoma without interrupting training or competition. Arch Otolaryngol Head Neck Surg 1989;115:202–6.
9. Koopmann CF, Coutthard SW. Management of hematomas of the auricle. Laryngoscope 1979;89:1172–4.
10. Eliachar I, Golz A, Joachims HZ, et al. Continuous portable vacuum drainage of auricular hematoma. Am J Otol 1983;4:141–3.
11. Lee EC, Soliman AM, Kim J. Traumatic auricular hematoma: a case report. J Craniomaxillofac Trauma 1977;3:32–5.
12. Ghanem T, Rasamny JK, Park SS. Rethinking auricular hematoma. Laryngoscope 2005;115:1251–5.
13. Fukase S, Ohta N, Inamura K, et al. Treatment of ranula with intra- cystic injection of the streptococcal preparation OK-432. Ann Otol Rhinol Laryngol 2003;112:214–20.
14. Ogita S, Tsuto T, Tokiwa K, et al. Intracystic injection of OK-432: a new sclerosing therapy for cystic hygroma in children. Br J Surg 1987;74:690–1.
15. Tsuchiya I, Kasahara T, Yamashita K, et al. Induction of inflammatory cytokines in the pleural effusion of cancer patients after the adminis- tration of an immunomodulator, OK-432: role of IL-8 for neutrophil infiltration. Cytokine 1993;5:595–603.
16. Kitsuki H, Katano M, Ikubo A, et al. Induction of inflammatory cytokines in effusion cavity by OK-432 injection therapy for patients with malignant effusion: role of interferon-gamma in enhancement of surface expression of ICAM-1 on tumor cells in vivo. Clin Immunol Immunopathol 1996;78:283–90.
17. Fukase Y, Fukase S, Sendo F. Priming activity for chemiluminescence reaction of PMN in the culture supernatant of streptococcal preparation (OK-432)–stimulated spleen cells. Microbiol Immunol 1988;32: 621–33.
18. Roh JL, Sung MW, Kim KH, et al. Treatment of branchial cleft cyst with intralesional injection of OK-432. Acta Otolaryngol 2006;126: 510–4.
19. Sung MW, Lee DW, Kim DY, et al. Sclerotherapy with Picibanil (OK-432) for congenital lymphatic malformation in the head and neck. Laryngoscope 2001;111:1430–3.
20. Giles WC, Iverson KC, King JD, et al. Incision and drainage followed by mattress suture repair of auricular hematoma. Laryngoscope 2007;
117:2097–9.
Subjects and Methods
brought to you by COREView metadata, citation and similar papers at core.ac.uk
provided by Elsevier - Publisher Connector
ORIGINAL RESEARCH–FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY
Treatment of auricular hematoma by OK-432
Toshinori Kubota, MD, Nobuo Ohta, MD, PhD, Shigeru Fukase, MD, PhD,
Yoshihisa Kon, MD, PhD, and Masaru Aoyagi, MD, PhD, Yamagata, Japan
Sponsorships or competing interests that may be relevant to con- tent are disclosed at the end of this article.
ABSTRACT
OBJECTIVES: Intralesional injection therapy with OK-432 was developed as a therapy for operatively difficult lymphangioma (cystic hygroma) and is currently becoming a first-choice treat- ment for this disease. The aim of this article was to evaluate the outcome and complications of the treatment of patients with au- ricular hematoma by OK-432 therapy. STUDY DESIGN: Case series with planned data collection. SETTING: Yamagata University School of Medicine. SUBJECTS AND METHODS: We tried this therapy in 21 patients with auricular hematoma between January 2001 and Feb- ruary 2009. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hema- toma. We performed this treatment on an outpatient basis without hospitalization. RESULTS: Disappearance or marked reduction of the lesion were observed in all patients who had this therapy, and local scarring and deformity of the auricle did not occur in any patients. As for side effects, local pain at the injection site and fever (37°C-38°C) were observed in a few of the patients who had this therapy, but such problems resolved within a few days. CONCLUSION: These results may allow us to speculate that intralesional injection therapy with OK-432 is simple, easy, safe, and effective and can be used as a substitute for surgery in the treatment of auricular hematoma.
© 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved.
Auricular hematoma is commonly encountered in the otolaryngology clinic. It occurs because of blunt
trauma to the auricle, and the properly unmanaged auricular hematoma can lead to infection, cartilage necrosis, contrac- ture, and neocartilage formation.1-3 Although there are a variety of treatments aimed at preventing these complica- tions and returning the auricle to its pretrauma form, im- proper treatment can result in the conspicuous cauliflower ear deformity.4-12 Thus, we have developed a new, simple, and safe method that can be used easily in private clinics and hospitals on an outpatient basis without hospitaliza- tion.13 This method is intralesional injection therapy with OK-432. OK-432 (Picibanil; Chugai Pharmaceutical Co.,
Received January 11, 2010; revised March 2, 2010; accepted March 3, 2010.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Nec doi:10.1016/j.otohns.2010.03.006
Tokyo, Japan) was originally developed as an immunother- apy agent for cancer. It is thought that its immunopotenti- ating actions are caused by strong local inflammation that promotes the release of various cytokines. It is widely ac- cepted that OK-432 is very effective for reduction of ascites and pleural effusion in patients with carcinomatous perito- nitis and pleuritis.13 When it is injected into the peritoneal or pleural cavity, reduction of ascites and pleural effusion occurs and adhesion of the cavity develops. Ogita et al first reported intracystic injection therapy with OK-432 for lym- phangioma in 1987.14 This therapy has become a treatment of first choice for lymphangioma in Japan, because it is effective and safe. The purpose of this article is to study the effectiveness of intralesional injection therapy with OK-432 in patients with auricular hematoma.
Subjects and Methods
Subjects This was a prospective clinical study of patients with au- ricular hematoma receiving intralesional injection of OK- 432 from January 2001 to February 2009. Twenty-one pa- tients were diagnosed as having auricular hematoma during the study. The patients ranged from 15 to 78 years of age. All patients were male and were treated on an outpatient basis without hospitalization. No patients had penicillin allergy. This study was approved by the Institutional Re- view Board of our institution, and informed consent was obtained from each patient.
Intralesional Injection of OK-432 We prepared 0.5 Klinische Einheit (KE) of OK-432 diluted with 0.2 mL saline solution. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hematoma. There was no resistance in cases of successful injection into the hematoma.
Aspiration On the second day after the injection, the swollen auricular hematoma was punctured by a syringe with a 20-gauge needle, and the intralesional fluid was aspirated as much as possible. The intralesional fluid was relatively viscous, so it
k Surgery Foundation. All rights reserved.
864 Otolaryngology–Head and Neck Surgery, Vol 142, No 6, June 2010
was necessary to use a larger needle for aspiration at this time.
Follow-up All patients were regularly observed for a mean of 13.1 months (range 4-38 months) after the last injection. To treat fever, we gave analgesics for three to five days to all patients. Analgesics were prophylactically given to all pa- tients in the present study to treat potential fever. The auricular skin became red and indurated on the day after injection, and we punctured the skin over the auricular hematoma and aspirated the fluid on the second day after injection. We examined all patients on days 2, 7, 14, and 28 after OK-432 injection and judged the response between four and six weeks after injection. In case the response was insufficient, we repeated the same therapy with a 100 per- cent increase of OK-432. The “cure” and “marked reduc- tion” of auricular hematoma were defined, respectively, as a negative palpation and a decrease of more than one half compared with pretreatment size.
Results
A total of 21 patients were enrolled in this study. The demographic clinical data of 21 eligible patients are listed in Table 1. The mean age of patients was 43.1 years (range 15-78 years). Maximum hematoma diameters ranged from 2.7 to 6.7 cm (mean 3.8 cm). Twenty cases of auricular hematoma were cured (follow-up for more than 4 months after the last injection with no recurrence) after injection
Table 1
Sex Age Side Size No. of
injections Total
1 M 52 L 3.8 cm 1 0.5 2 M 41 L 3.5 cm 2 1 3 M 72 R 4.3 cm 1 0.5 4 M 16 R 6.7 cm 5 3.5 5 M 58 L 3.2 cm 1 0.5 6 M 29 L 2.9 cm 1 0.5 7 M 17 L 2.8 cm 1 0.5 8 M 53 R 3.6 cm 1 0.5 9 M 27 L 3.9 cm 1 0.5
10 M 55 L 4.1 cm 1 0.5 11 M 15 R 5.9 cm 3 2 12 M 45 L 4.0 cm 1 0.5 13 M 58 L 3.2 cm 1 0.5 14 M 36 R 4.6 cm 1 0.5 15 M 32 R 3.8 cm 1 0.5 16 M 78 R 2.7 cm 1 0.5 17 M 45 R 3.3 cm 1 0.5 18 M 19 L 3.8 cm 1 0.5 19 M 67 L 4.1 cm 1 0.5 20 M 35 L 3.2 cm 1 0.5 21 M 55 R 2.9 cm 1 0.5
KE, Klinische Einheit.
with OK-432 solution, administered one to three times. One patient had a marked reduction of auricular hematoma, but not a complete elimination, even after receiving the maxi- mum of five injections of OK-432 (case number 4). The number of treatments ranged from one to five (mean 1.3), and mean follow-up period was 13.1 months (range from 4 to 38 months). The outcome of OK-432 injection in auric- ular hematoma seemed not to depend on the size and loca- tion or the patient’s age. There were no serious complica- tions, although patients experienced fever (37.5°C-38°C ) for a few days after injection, usually controlled by antipy- retics. No infection or abscesses developed after OK-432 injections. None of the patients had evidence of scar on the skin at the injection site. Other side effects of the strepto- coccal preparation, such as post–rheumatic fever sequelae and glomerulonephritis, were not observed in any cases (Table 2). This therapy was undertaken for all patients with auricular hematoma on an outpatient basis without hospi- talization.
Discussion
There are various conservative and surgical treatments for auricular hematoma, including needle aspiration, short-term bolsters, incision and drainage, and drainage followed by application of a pressure dressing.1-12 Permanent elimina- tion of the dead space after evacuation of the hematoma has always been the main problem. Some patients are not suc- cessfully managed, and these procedures result in the conspicuous cauliflower ear deformity.2-12 OK-432 is a ly-
Follow-up Results Further treatment
30 months Cure None 4 months Cure None
12 months Cure None 38 months Marked reduction None 27 months Cure None 6 months Cure None 4 months Cure None
14 months Cure None 7 months Cure None 9 months Cure None
21 months Cure None 5 months Cure None
17 months Cure None 13 months Cure None 15 months Cure None 19 months Cure None 6 months Cure None 7 months Cure None 8 months Cure None 7 months Cure None 6 months Cure None
oma
dose
KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE KE
865Kubota et al Treatment of auricular hematoma by OK-432
ophilized streptococcal preparation made by penicillin treat- ment of the Su-strain of A-group streptococcus, and it was developed as an immunotherapy agent for cancer.13 When it is administered, strong local inflammatory reaction is caused by activation of neutrophils and monocytes, leading to cytokine production.15-17 Ogita et al first reported that intralesional injection therapy with OK-432 was effective for the lymphangioma.14 The working mechanism of OK- 432 in lymphangioma is that it immediately evokes inflam- mation and filtration of inflammatory cells into the cystic spaces. The accelerated lymph drainage and increased lymph flow lead to shrinkage of the cystic spaces. We reported that intralesional injection therapy with OK-432 was also effective in treatment of ranula.13 Roh et al have demonstrated that sclerotherapy with OK-432 was effective in treatment of branchial cleft cyst.18 OK-432 seems to be more safe and effective than other sclerosing agents such as boiling water, hypertonic saline, ethanol, tetracycline, cy- clophosphamide, sodium morrhuate, or bleomycin. How- ever, these sclerosing agents have shown limited success and systemic side effects of unpredictable scarring caused by spreading agents beyond the endothelial lining of the hematoma. Bleomycin can cause several side effects, in- cluding fibrosis of the lung.
Auricular hematoma arises from blunt trauma to the auricle. Shearing forces between the anterior auricular skin and underlying cartilage are believed to be responsible for the hematoma.1 The location of the hematoma has been classically described as between the perichondrium and cartilage; however, in some patient cases, hematoma can arise within the cartilage itself. OK-432 can induce very strong inflammation at the injection sites in auricular hema- toma. No deformity or infection was observed after sclero- therapy with OK-432.13,14,18,19 The complication rate of sclerotherapy is minimal. Sclerotherapy with OK-432 does not require patient admission or leave any scar on the skin at the injection site. Sclerotherapy is economically and cosmetically more advantageous than surgery. Our study is the first showing that auricular hematoma can be treated by the use of OK-432 in a larger patient series. Our study was limited by lack of a control group. Randomized controlled trials comparing OK-432 injection with simple aspiration, incision, or saline injection may be warranted. However, our results may be compared with historical control groups of simple aspiration and incision. Giles et al reported that the recurrence rates of needle drainage, incision and drainage with wick placement, and incision and drainage with mat- tress suture were 75 percent, 50 percent, and 5.3 percent, respectively.20 Needle aspiration alone and needle aspira- tion and drain placement are not sufficient treatments. Giles et al also reported 28 treatments in 23 ears. In the present study, 28 treatments were performed in 21 ears; however, 18 of 21 patients required only one treatment. Schuller et al demonstrated that only 14 of 24 patients with auricular hematoma were successfully treated initially.8 Two suffered
reinjury requiring treatment, and these ears were reported to
have slight thickening after healing.8 From the point of cost effectiveness, OK-432 therapy needs serial office visits, while agent and office treatment by the other modalities (aspiration, drainage) is considered inexpensive and re- quires no special equipment or medication. Regarding re- currence and number of required treatments, OK-432 ther- apy is at least comparable to other published techniques. There are collateral advantages regarding OK-432 therapy, as enumerated here: 1) The time for the procedure is brief, and it seems particularly suitable for children and other patients who cannot tolerate long procedures. 2) No local anesthesia was required during treatment. 3) The treatment was painless; therefore it can be well tolerated by children and nervous patients. 4) Secondary infection and hemor- rhage are rare. The auricular hematoma can be primarily treated with intralesional injection therapy with OK-432, several times if needed. A surgical procedure is only rec- ommended for cases with fibrous tissue and neocartilage formation.
Conclusions
Our results suggest that the treatment of auricular hematoma by OK-432 is simple, easy, safe, and effective therapy that results in complete or significant decrease in the volume of auricular hematoma, despite some incidence of recurrence. This therapy is a potentially curative procedure that may be used as a first-choice treatment for auricular hematoma
Table 2
Treatment Previous surgery, no. (%) 1 (5) Injected OK-432 solution
Median volume, mL (range) 0.2 (0.2-0.5) Median dose, KE (range) 0.55 (0.5-1) Total dose, KE (range) 0.55 (0.5-3.5) No. of treatments, median (range) 1.3 (1-5) Follow-up, months 13.1 (4-38) Further treatment 0
Response, no. (%) Cure 20 (95) Failure 0 Marked volume reduction 50%* 1 (5) Minimal volume reduction 50%* 0 Recurrence after cure 0
Side effects, no. (%) Low-grade fever 2 (10) Tolerable pain and local tenderness 4 (20) Local scar 0 Skin pigmentation 0 Auricular deformity 0
KE, Klinische Einheit. *Reduction of original hematoma size.
before considering surgical procedures.
866 Otolaryngology–Head and Neck Surgery, Vol 142, No 6, June 2010
Acknowledgment
This manuscript is dedicated to Professor Masaru Aoyagi, chairman, De- partment of Otolaryngology, Yamagata University, School of Medicine, who recently retired.
Author Information
From the Department of Otolaryngology, Yamagata University School of Medicine, Yamagata, Japan.
Corresponding author: Dr. Nobuo Ohta, Department of Otolaryngology, Yamagata University School of Medicine, 2-2-2, Iida-nishi Yamagata 990-9585 Japan.
E-mail address: [email protected].
This article was presented at the 2009 AAO–HNSF Annual Meeting & OTO EXPO, San Diego, CA, October 4-7, 2009.
Author Contributions
Toshinori Kubota, data analysis, article revision; Nobuo Ohta, concep- tion and data analysis, design, article revision, final approval; Shigeru Fukase, conception and design, article revision; Yoshihisa Kon, data analysis, article revision; Masaru Aoyagi, conception and design, final approval.
Disclosures
Competing interests: None.
Sponsorships: Supported by grants from the Ministry of Education, Sci- ence, Sports and Culture (Grant in Aids for Scientific Research C 19591955).
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4. O’Donnell BP, Eliezri MD, Eliezri YD. The surgical treatment of
traumatic hematoma of the auricle. Dermatol Surg 1999;25:803–5.
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Subjects and Methods
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